Aspira Drainage Kit 4992301Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741045035), received between Jun 9, 2017 and Apr 17, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1599-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2018Insufficient Flow or Under Infusion

  IT WAS REPORTED BY THE PATIENT THAT THE DRAINAGE ON HER ASPIRA BAG HAS DECREASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7438562 ↗
• MalfunctionApr 12, 2018Inflation Problem; No Device Output

  IT WAS REPORTED THAT THE HOME HEALTH NURSE HAS A PATIENT WITH AN ASPIRA PERITONEAL CATHETER THAT WAS PLACED APPROXIMATELY ONE MONTH AGO. SHE REPORTS THAT IT DRAINED PROPERLY AT THE HOSPITAL AND SHE WAS ABLE TO DRAIN IT TWO DAYS AGO. THE PATIENT'S ABDOMEN IS SWOLLEN, BUT THE BULB WILL NOT INFLATE AFTER IT IS SQUEEZED AND FLUID IS NOT DRAINING. SHE STATES THIS HAPPENED WITH TWO BAGS.

  Patient problems: Swelling

  MAUDE report 7426726 ↗
• MalfunctionApr 12, 2018No Device Output

  PATIENT REPORTED THAT HIS ASPIRA BAG WILL NOT DRAIN. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426451 ↗
• MalfunctionJun 9, 2017Inflation Problem; Device Operates Differently Than Expected; Output Problem

  ON (B)(6) 2017 - HOSPICE NURSE REPORTED TO MEDICAL SERVICES AND SUPPORT (MS&S) THAT IN HOME PATIENT'S ASPIRA PLEURAL CATHETER HAS NOT BEEN DRAINED SUCCESSFULLY SINCE (B)(6) 2017. NURSE STATED THERE WAS "PINKISH TINTED FLUID" IN THE EXTERNAL SEGMENT. AFTER SQUEEZING THE BULB, THE BULB WOULD NOT RE-INFLATE NOR DRAIN FLUID. MS&S ADVISED THE NURSE THAT THE PATIENT MAY NEED TO BE SEEN IN THE ER SINCE THE CATHETER WILL NOT DRAIN. THE CATHETER COULD BE PARTIALLY OCCLUDED. NURSE CONFIRMED THAT THERE WERE NO KINKS IN THE LINE, NO CLAMP ON THE CATHETER AND THAT THE BAG IS BELOW THE AREA NEEDING TO BE DRAINED. THE BAG/CATHETER CONNECTION WAS CHECKED, PATIENT WAS REPOSITIONED AND AFTER MILKING THE LINE, THE NURSE WAS ONLY ABLE TO GET A FEW MLS TO DRAIN. MS&S STATED THE CATHETER MAY NEED TO BE FLUSHED WITH SALINE OR FIBRINOLYSIS AGENT. THE NURSE DID NOT HAVE A SYRINGE FOR FLUSHING AT THE TIME. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6632469 ↗